14 results
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29ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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INCLUSIVE TAPERED IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
Alleset
FDA UDI
GRI Medical & Electronic Technology Co., Ltd.·16931918179827·Ophthalmic Drape_Full body_Blue SMS Fabric_Inci...
BIOHORIZONS PLASTIC TEMPORARY ABUTMENTS
FDA 510(k)
FDA Class 2
·Dental
PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PLATE, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES GRENCHEN·Product code HRS·January 30, 2017
MINI-CAP
FDA Adverse Event
Death
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 8, 2013
DEPUY ASR XL FEM IMP SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL, LTD.·Product code KWA·May 18, 2011
POLYFLUX LR CAPILLARY DIALYZER
FDA Adverse Event
Malfunction
·GAMBRO DIALYSATOREN GMBH·Product code MSF·September 4, 2008
PREVENA PLUS INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC·Product code OMP·September 24, 2021
PREVENA PLUS¿ INCISION MANAGEMENT SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 19, 2019
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Injury
·CONMED UTICA·Product code GEI·May 18, 2023
AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE
FDA Adverse Event
Malfunction
·CONMED UTICA·Product code GEI·May 25, 2023
Integrity 1.1. Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes.
FDA Enforcement
Class II
·Terminated·Elekta, Inc.·April 9, 2014
ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear
FDA Enforcement
Class II
·Ongoing·Elekta, Inc.·December 13, 2023